Healon D Recall
The lawyers in the drug safety group at 888-422-2882 are investigating this device. We're licensed in and work together in Alabama, New York, Florida, Georgia, Connecticuit, Texas, Oklahoma, and California:
The U.S. Food and Drug Administration announced a Class I recall of Lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube. Healon D® OVD was designed to coat the cornea and remain in place throughout an entire surgical proces
If you have had any eye surgery that resulted in a serious eye inflammation, the Healon device could have played a role.
AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS, Toxic Anterior Segment Syndrome. Endotoxin are toxins associated with certain bacteria.
If you had eye surgery that involved the now recalled AMO Healon D device and had serious eye inflammation, Toxic Anterior Segment Syndrome (TASS), or another eye condition that you think may be linked to this recalled product, call us or email us. The Toll Free #is 888-422-2882.
Learn more about TASS:
TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens).
* SEVERE CASES OF TASS can cause permanent harm, and if symptoms still are present after six weeks, the eye is not likely to recover.
* EARLY DIAGNOSIS AND TREATMENT are effective in preventing permanent damage, but often TASS is mistakenly diagnosed as infectious endophthalmitis for which treatment is completely different.
DIFFERENCES BETWEEN TASS AND INFECTIOUS ENDOPHTHALMITIS
The onset of signs and symptoms, type of symptoms, and response to therapy all have a role in differentiating TASS from infectious endophthalmitis (Table 1). (8) Symptoms that can occur with both TASS and infectious endophthalmitis include decreased or blurred vision; (1,2,8) hypopyon (ie, a layer of pus inside the eye between the cornea and iris); and fibrin (1,2,8) and conjunctival redness. (1,2) To differentiate between the two diagnoses, an ophthalmologist conducts a complete evaluation, including
* fundus examination,
* gonioscopy,
* slit lamp examination,
* tonometry, and
* aqueous and vitreous needle aspiration (Table 2). (3)
ONSET. Usually, TASS has an earlier onset (ie, 12 to 24 hours after surgery) (1,8,9) than infectious endophthalmitis. (2,4,8) At times, TASS begins later the same day of surgery, (10) although the toxic reaction can have a delayed onset. Infectious endophthalmitis usually is apparent three to seven days postoperatively, (1,2,5) Sometimes, infectious endophthalmitis occurs weeks to months after surgery, particularly if less virulent or fungal organisms are present. (1)
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